Performance of Red Tinted Contact Lenses on Colour Defects

Color Vision Defects Clinical Trial

— CL  

Official title:

The Performance of Red Tinted Contact Lenses of Various Tones on Colour Deficient Subjects: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05643222
• Other study ID #: UKM PPI/111/8/JEP-2021-145
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: December 2022
• Source: National University of Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to relate and compare the performance of 4 types of red-tinted contact lenses (CL) with the Total Error Score (TES) from the Farnsworth-Munsell 100 Hue test on colour deficient subjects. Only 6 subject with colour vision defect was tested in this study.

Description:

Six congenital CVD subjects were recruited. After colour vision screening using Ishihara plate, the Farnsworth-Munsell 100 Hue test was carried out to determine the type and severity of colour vision deficiency. Four types of red-tinted CL (Type A, B, C and D) were used. The performance of each of these lenses was determined through the comparison of error scores in the Ishihara test before and after wearing tinted contact lens on only the non-dominant eye. Then, the transmittance of each tinted CL was determined using a spectrophotometer. All these lenses were fitted on the subjects in one day where the subjects were given a 30-minute break for each intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: July 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age range 18-40 years

• all sex

• color defect diagnosed with Ishihara Test

• no contraindication in contact lens wear

Exclusion Criteria:

• have ocular and systemic diseases

Related Conditions & MeSH terms

• Blindness
• Color Vision Defects

Intervention

Device:
• red tint contact lenses
to compare the performance of these lenses.

Locations

Country	Name	City	State
Malaysia	Optometry Clinic	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (1)

Cole BL, Lian KY, Lakkis C. Using clinical tests of colour vision to predict the ability of colour vision deficient patients to name surface colours. Ophthalmic Physiol Opt. 2007 Jul;27(4):381-8. doi: 10.1111/j.1475-1313.2007.00493.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The lens which gives the best result in TES value	The highest TES value scored showed higher performance in colour vision. TES is an automated, generated value that calculates the number of tiles placed incorrectly and scales the value for uniform analysis. Average TES scores range from thirty to forty in series tests; while scores exceeding seventy can point to a marker for color blindness. Lower scores are intended to point to significantly increased color vision accuracy, as the TES score is directly correlated to the number of tiles incorrectly identified	30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed.
Primary	The lens which gives the best performance in ES value	The highest score achieved using Ishihara Test indicates the best red tint lens. The current passing score is 12 correct of 14 red/green test plates (not including the demonstration plate). Research has shown that scores below twelve indicate color vision deficiency, and twelve or more correct indicate normal color vision, with 97% sensitivity and 100% specificity	30 minutes after lens adaptation. Lens is removed immediately after the assessment is completed